Senior Quality Engineering Manager - Design & Development

Senior Quality Engineering Manager - Design & Development

Mountain View, CA

Senior Quality Engineering Manager

Verb Surgical - a Google and Johnson & Johnson joint venture!

Mission:

Our Quality Leader will drive exceptional product quality, safety, design and reliability through the R&D/Product Development and Quality teams and into the product. This important technical position will have direct influence on component, assembly, and final product quality for R&D and production builds and release to market. This individual will manage a team of highly talented quality engineers and will actively participate in risk management, design concepts, design specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, project planning, and associated documentation. The Quality Leader provides coaching and mentoring to engineers and other project team members on the Quality Management System and compliance to external standards.

Key Interfaces Interact on a daily basis with R&D, Manufacturing/NPI, Quality and Purchasing resources as well as Marketing and the Program Management team to drive quality into the product design, advise the team on risks and standards and to mentor team members and engineers.

Review technical problems and departmental procedures and recommends solutions to problems or changes in procedures.

Provide authoritative guidance on ISO, QSR and external standards requirements to the new product development teams.

Lead Risk Management efforts in accordance with ISO 14971 and Design Control efforts in line with ISO 13485 and 21CFR 820.

Train and mentor engineers and other project team members on best practices in quality engineering and regulatory compliance to external standards.

Ensure maintenance of and compliance to the most recent versions of all applicable international quality system and product quality standards.

Champion processes covering Quality Engineering and Quality Management to train, support, and encourage team members in the use of quality tools such as root cause analysis, risk analysis, FMECA, DOE, and statistical methods.

Working knowledge of statistics for R&D, quality, reliability and inspection.

Comfortable and effective in a startup environment.

This position requires excellent verbal, written (English) and interpersonal communications skills with proven ability to translate technical information into effective procedures, plans, specifications and agreements.

Ability to effectively present information in one-on-one and small group situations to supplier personnel, partners, consultants and employees at all levels of the organization.

Ability to read, analyze, and interpret applicable scientific and technical journals, and legal documents. Ability to respond to common inquiries from auditors, notified bodies, regulatory agencies, or members of the business community.

Experience and Qualifications (include Years of Experience, Leadership, Industry, etc.):

8+ years of experience in a quality engineering role in the medical device industry with experience in complex systems strongly preferred. 2+ years in a manager role.

Working knowledge of biocompatibility and sterilization validation is a plus.

UDI labeling, WEEE and RoHS/REACH compliance knowledge is a plus.

Who is Verb Surgical?

Verb Surgical™ is shaping the future of surgery. A new future, a future unimagined even a few years ago, which will involve machine learning, robotic surgery, instrumentation, advanced visualization, and data analytics. A future of surgery that aims to achieve improved patient outcomes, lower costs, and greater hospital efficiency.

Verb Surgical was founded with technology, expertise, and funding from Verily (formerly Google Life Sciences) and Ethicon, a medical device company in the Johnson & Johnson family of companies. This company will continue in strong partnership with Verily and Johnson & Johnson (Google and Johnson & Johnson Team for Robotic Surgery) to advance the surgical tools and capabilities available to surgeons and OR professionals today.

Date posted:

Apr 20, 2020

Verb Surgical is building the future of digital surgery through robotics, enhanced visualization, and machine learning.